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Percutaneous Therapy

MitraClip System for Heart Failure (COAPT Trial)

N/A
Waitlist Available
Led By Michael Mack, MD
Research Sponsored by Abbott Medical Devices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Symptomatic functional MR (≥3+) due to cardiomyopathy of either ischemic or non-ischemic etiology determined by assessment of a qualifying transthoracic echocardiogram (TTE) obtained within 90 days and transesophageal echocardiogram (TEE) obtained within 180 days prior to subject registration, with MR severity based principally on the TTE study, confirmed by the Echocardiography Core Lab (ECL). The ECL may request a transesophageal echocardiogram (TEE) to confirm MR etiology.
Functional MR requires the presence of global or regional left ventricular wall motion abnormalities, which are believed to be the primary cause of the MR. If a flail leaflet or other evidence of degenerative MR is present, the subject is not eligible even if global or regional left ventricular systolic dysfunction is present.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

COAPT Trial Summary

This trial is testing the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe or severe functional mitral regurgitation in Symptomatic Heart Failure Subjects. It is a randomized controlled trial with 610 subjects. A subset of patients will also be registered in a cardiopulmonary exercise sub-study.

Who is the study for?
This trial is for adults with symptomatic heart failure and moderate-to-severe functional mitral regurgitation who are not suitable for surgery. They should have been hospitalized for heart failure or have certain levels of natriuretic peptides, indicating heart stress. Patients must be stable on optimal medical therapy and capable of giving informed consent.Check my eligibility
What is being tested?
The COAPT Trial tests the safety and effectiveness of the MitraClip System in reducing mitral regurgitation in patients with heart failure. It's a randomized controlled trial where some patients receive the device while others continue standard care without it.See study design
What are the potential side effects?
Potential side effects from the MitraClip procedure may include bleeding at the access site, infection, complications related to catheter insertion like blood vessel damage, arrhythmias (irregular heartbeat), or worsening of kidney function.

COAPT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have severe mitral regurgitation due to heart muscle issues, confirmed by recent heart scans.
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My heart valve issue is due to heart muscle problems, not a damaged valve.
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My heart function test was done after my treatment was stable and any major changes.
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My heart condition has been treated according to current standards.
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I've been hospitalized for heart failure in the last year or have high BNP/NT-proBNP levels.
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My heart failure markers were measured after my treatment was stable and any major changes.
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My heart's pumping chamber size is within normal limits on a recent echo test.
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I understand and agree to possibly receiving non-surgical treatment if placed in the Control group.
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My heart condition will be treated with medication, not surgery, as agreed by my medical team.
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I am 18 years old or older.
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I have some limitations on physical activity due to heart issues.

COAPT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Effectiveness Endpoint
Primary Safety Endpoint - Percentage of Participants With Freedom From Device Related Complications at 12 Months
Secondary outcome measures
Change in Distance Walked on the 6 Minute Walk Test (6MWT Distance or 6MWD)
Change in Left Ventricular End Diastolic Volume (LVEDV)
Change in Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
+18 more
Other outcome measures
6MWD
Average Dosages of GDMT
Average Dosages of Guideline Directed Medical Therapy (GDMT)
+69 more

COAPT Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: MitraClip SystemExperimental Treatment1 Intervention
Percutaneous mitral valve repair using MitraClip System
Group II: COAPT CAS GroupExperimental Treatment1 Intervention
Percutaneous mitral valve repair using MitraClip System
Group III: Control GroupActive Control1 Intervention
Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.

Find a Location

Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor
635 Previous Clinical Trials
404,459 Total Patients Enrolled
Michael Mack, MDPrincipal InvestigatorBaylor Health Care System
5 Previous Clinical Trials
1,846 Total Patients Enrolled
Gregg Stone, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL
13 Previous Clinical Trials
6,481 Total Patients Enrolled

Media Library

MitraClip System (Percutaneous Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01626079 — N/A
Mitral Regurgitation Research Study Groups: MitraClip System, Control Group, COAPT CAS Group
Mitral Regurgitation Clinical Trial 2023: MitraClip System Highlights & Side Effects. Trial Name: NCT01626079 — N/A
MitraClip System (Percutaneous Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01626079 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitment efforts for this research project still ongoing?

"According to clinicaltrials.gov, this medical trial has ceased recruitment of patients since its last edit on September 21st 2022. Fortunately, there are 787 additional studies that participants may join at the present moment."

Answered by AI

Is this study available in multiple locations across North America?

"The clinical trial is accepting applications from 86 different sites including the University of Virginia in Charlottesville, St. Vincent Heart Center of Indiana in Indianapolis and Henry Ford Hospital in Detroit among many others."

Answered by AI

What purpose is this research endeavor striving to fulfill?

"This clinical trial, which is expected to take 12 months in total, has Primary Effectiveness Endpoint as its primary outcome. Two secondary outcomes will also be assessed: the Six Minute Walk Test (6MWT Distance or 6MWD) and potential Renal Complication With Requirement for Dialysis (COAPT CAS Study Analysis). Additionally, Major Vascular Complications (COAPT CAS Study Analysis) will be tracked throughout the duration of this experiment."

Answered by AI

Who else is applying?

What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
~62 spots leftby Mar 2025